Drug Recalls Center

895 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

895
Total Drug Recalls
24
High Risk Medications
FDA
Official Source

Important Medication Safety Information

  • Do not stop taking prescribed medications without consulting your healthcare provider
  • Contact your pharmacist or doctor if you have a recalled medication
  • Check lot numbers carefully - not all batches may be affected
  • Return recalled medications to your pharmacy for proper disposal

Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.

HIGHFDA DEVICE

Affixus Antegrade Femoral Nailing System Recalled Over Fatigue Risk

Affixus recalled 22 units of its antegrade femoral nailing system on December 2, 2025, due to a risk of implant fatigue fracture. The defect may lead to serious health complications including tissue damage and pain. Consumers and healthcare providers must stop using the affected implants immediately.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Affixus Antegrade Femoral Nails Recalled Over Fracture Risk

Zimmer, Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, risking implant fatigue fracture. This defect can cause severe health issues, including pain and tissue damage requiring surgery.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Affixus Femoral Nailing System Recalled Over Fracture Risk

Affixus recalled its Antegrade Femoral Nailing System on December 2, 2025, due to a potential implant fatigue fracture risk. The recall affects 22 units distributed nationwide in 14 states. Patients should stop using the affected devices immediately to avoid serious health risks.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Affixus Antegrade Femoral Nails Recalled Over Fracture Risk

Zimmer Inc. recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have undersized distal diameters, leading to potential fractures. Users should stop using the product immediately and contact their healthcare provider.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Zimmer Recalls Affixus Femoral Nails Due to Fracture Risk

Zimmer Inc. recalled 22 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have undersized distal diameters, risking implant fatigue fractures. Consumers should stop using the device immediately and follow manufacturer instructions.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Zimmer Recalls Affixus Antegrade Femoral Nails Over Fracture Risk

Zimmer recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025, due to a risk of implant fatigue fracture. Affected implants may cause serious health issues, including tissue damage and pain. Healthcare providers must stop using the device immediately and follow recall instructions.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Cook Medical Recalls Introducer Sheaths Over Manufacturing Errors

Cook Medical recalled 7,952 Flexor Check-Flo introducers and sets on November 26, 2025. The devices may have been manufactured out of specification, potentially posing serious risks to patients. Health care providers and patients should stop using these products immediately.

Cook
Cook Medical
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HIGHFDA DEVICE

Cook Medical Recalls Transjugular Liver Access Set Over Hazardous Manufacturing

Cook Medical recalled 23 units of its Transjugular Liver Access Sets on November 26, 2025. The recall follows concerns that products may have been manufactured out of specification, leading to potential use errors. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Cook
Cook Medical
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HIGHFDA DEVICE

Ferndale Laboratories Recalls Mastisol Liquid Adhesive Over Hazard

Ferndale Laboratories recalled 24,589 vials of Mastisol Liquid Adhesive due to a defect. The butyrate tube may crack during use, making the product unusable. The recall affects products distributed in the U.S. and the U.K., announced on November 25, 2025.

Ferndale Laboratories
Butyrate tube
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HIGHFDA DRUG

Breckenridge Recalls Duloxetine Capsules Over Chemical Hazard

Breckenridge Pharmaceutical, Inc. recalled 7,389 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations and the presence of N-nitroso-duloxetine impurity above FDA limits. Consumers should stop using the product immediately and contact healthcare providers for guidance.

DULOXETINE
CGMP Deviations;
Read more
HIGHFDA DRUG

Duloxetine Capsules Recalled Over High N-Nitroso Impurity Risk

Towa Pharmaceuticals recalled 3,397 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations resulting in N-nitroso-duloxetine levels exceeding FDA limits. Consumers must stop using the product immediately.

DULOXETINE
CGMP Deviations;
Read more
HIGHFDA DEVICE

Draeger Vapor 2000 Anesthetic Vaporizer Recalled Over Impurities

Draeger, Inc. recalled 431 units of the Vapor 2000 anesthetic vaporizer on November 24, 2025. A component of the devices contained impurities and did not meet specifications, posing a high hazard risk. Healthcare providers and patients should cease use immediately and follow recall instructions.

Draeger
A certain
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HIGHFDA DEVICE

ICU Medical Recalls LifeShield Infusion Software Over Delivery Risk

ICU Medical recalled the LifeShield Infusion Safety Software Suite v2.2 on November 24, 2025. The software fails to operate as expected for migrated libraries, risking medication delivery errors. The recall affects seven customers across several states, including California and New York.

ICU Medical
For certain
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HIGHFDA DEVICE

ICU Medical Recalls LifeShield Infusion Safety Software Due to Risk

ICU Medical recalled LifeShield Drug Library Management software on November 24, 2025. A software issue limits concentration precision to one decimal place, risking incorrect drug dosages. Users should stop using the product immediately and follow recall instructions.

ICU Medical
Software issue
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HIGHFDA DRUG

Glenmark Pharmaceuticals Recalls Bisoprolol Tablets Due to Contamination

Glenmark Pharmaceuticals recalled over 11,000 bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets on November 21, 2025. Testing revealed traces of ezetimibe, posing a health risk. Consumers should stop using the product immediately and contact their healthcare provider.

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Cross Contamination
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HIGHFDA FOOD

A New Life Herbs Recalls Ear Drops Over Misbranding Issues

A New Life Herbs, LLC recalled 22 bottles of Mullein flower alcohol tincture on November 20, 2025. The product is misbranded due to unapproved drug claims and lack of a Supplement Facts label. Consumers should stop using this product immediately.

A New Life Herbs
Unapproved drug
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